A School-Based HIV/STD Prevention Program to Reduce Risky Sexual Behaviors Among Adolescents in Liberia
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| ClinicalTrials.gov Identifier: NCT00698321 |
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Recruitment Status :
Completed
First Posted : June 17, 2008
Last Update Posted : May 20, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Behavioral: HIV/STD prevention curriculum Behavioral: General health promotion curriculum | Not Applicable |
Currently, more than 60 million people have been diagnosed with HIV/AIDS worldwide. It is estimated that about two-thirds of all HIV infections are among people in Africa. The African country of Liberia, in particular, is experiencing an increase in HIV/sexually transmitted disease (STD) infections and is in need of improved HIV/STD-related prevention programs. With the majority of the new infections occurring among people who are between 15 and 29 years old, new HIV/STD prevention programs are needed to educate youth about proper condom use and risks associated with sexual behaviors. Previous research has suggested that behavioral interventions can reduce adolescents' sexual behaviors that are tied to risk of acquiring STDs. The evidenced-based HIV prevention program, Making Proud Choices, is an intervention originally designed for community settings in the United States, but is currently being adapted in schools of certain sub-Saharan African countries. Adapting this community-based curriculum to school-based settings and cultural contexts within Liberia may be effective in reducing risky sexual behaviors in Liberian adolescents. This study will compare the effectiveness of a school-based HIV/STD prevention program that draws on the curriculum of Making Proud Choices versus a general health promotion program in reducing sexual risk behaviors of youth attending school in Liberia.
Participation in this study will involve two phases. Phase 1 will last 8 months and will be used to adapt the community-based curriculum of Making Proud Choices to school-based settings and contexts within Liberia. Data to guide the integration and cultural adaptation of the curriculum will be collected from school administrators, students, health educators, and community-based organizations through focus groups, group discussions, and interviews.
Phase 2 will last about 12 months and will include junior high schools in Liberia. Participating schools will be assigned randomly to provide the adapted HIV prevention curriculum or a general health promotion curriculum. Before starting course modules, students receiving either curriculum will complete questionnaires about their risk-associated sexual behaviors and knowledge about condom use and abstinence. Both curriculums will include eight 1-hour modules delivered weekly over 8 weeks. The HIV prevention curriculum will focus on increasing knowledge about preventing HIV, STDs, and pregnancy; improving condom use skills; increasing confidence in the ability to negotiate safer sex and to use condoms correctly; and lowering the incidence of sexual-risk behavior. The general health promotion curriculum will focus on teaching students healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance abuse. All participants will repeat the initial questionnaires immediately after completing the curriculum and 3, 6, and 9 months after the curriculum ends.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 866 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Liberia School-Based HIV/STD Prevention Program |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | March 2011 |
| Actual Study Completion Date : | March 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Participating schools will deliver HIV/STD prevention modules.
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Behavioral: HIV/STD prevention curriculum
The curriculum will include eight 1-hour HIV prevention modules administered weekly for 8 weeks. The modules will educate youth about risky sexual behaviors and will provide them with knowledge and skills necessary to reduce their risk of STDs, HIV, and pregnancy by abstaining from sex or using condoms if they choose to have sex. The curriculum is based on cognitive behavioral theories, focus groups, and the researchers' experience working with youth.
Other Name: Making Proud Choices! |
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Active Comparator: 2
Participating schools will deliver general health promotion modules.
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Behavioral: General health promotion curriculum
The curriculum will include eight 1-hour general health modules administered weekly for 8 weeks. The curriculum will focus on teaching students healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance abuse. |
- Frequency of unprotected sex [ Time Frame: Measured at Month 12 ]
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| Ages Eligible for Study: | 13 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- A 6th or 7th grader attending school in Liberia
Exclusion Criteria:
- Not enrolled in the study schools
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698321
| Liberia | |
| University of Liberia | |
| Monrovia, Montserrado County, Liberia | |
| Principal Investigator: | Stephen B. Kennedy, MD, MPH | Pacific Institute for Research and Evaluation |
| Responsible Party: | Stephen B. Kennedy, Principal Investigator, Pacific Institute for Research and Evaluation |
| ClinicalTrials.gov Identifier: | NCT00698321 History of Changes |
| Other Study ID Numbers: |
R21MH082666 ( U.S. NIH Grant/Contract ) R21MH082666 ( U.S. NIH Grant/Contract ) DAHBR 9A-ASPA |
| First Posted: | June 17, 2008 Key Record Dates |
| Last Update Posted: | May 20, 2013 |
| Last Verified: | May 2013 |
Keywords provided by Stephen B. Kennedy, Pacific Institute for Research and Evaluation:
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HIV/STD Prevention HIV Seronegativity |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |